Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT04921917

Exercise and Soft Tissue Sarcoma

Led by Duke University · Updated on 2026-04-08

24

Participants Needed

1

Research Sites

452 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

U

University of North Carolina, Chapel Hill

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment.

CONDITIONS

Official Title

Exercise and Soft Tissue Sarcoma

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females within the ages of 18-85
  • Diagnosis of soft tissue sarcoma confirmed by an approved reference pathologist
  • Sarcoma located in the upper or lower extremity
  • Treatment plan includes neoadjuvant radiation therapy followed by surgical resection
  • Expected primary wound closure performed during surgery
  • Any disease stage
  • Any tumor grade
  • Any histologic subtype
  • First or recurrent sarcoma presentations
  • No vascular invasion or resection/repair/reconstruction causing decreased blood flow to the limb
  • No prior radiation therapy to tumor or surgical area before current treatment
  • Ability to comply with follow-up visits
  • Ability to provide own consent
Not Eligible

You will not qualify if you...

  • Under 18 years or over 85 years of age
  • Treatment plan does not include neoadjuvant radiation and surgical excision
  • Sarcoma located outside of the upper or lower extremity
  • Prior radiation therapy to the tumor or surgical area before current treatment
  • High dose steroid therapy (>5mg prednisone or equivalent) within last 30 days
  • Active chemotherapy treatment within last 30 days
  • Unable to provide informed consent (due to dementia, cognitive impairment, or non-English speaking)
  • Planned post-operative radiation therapy
  • Severe underlying cardiopulmonary disease
  • Prior surgery at disease site other than biopsy
  • Tumors ulcerative or fungating through dermis at presentation
  • Vascular invasion or surgery causing decreased blood flow to limb
  • Vascular disease causing clinical blood flow compromise to limb
  • Uncontrolled diabetes mellitus (with A1c >8)
  • Active deep vein thrombosis in treatment limb
  • Inability to comply with follow-up visits
  • Pregnant females (women of childbearing potential must have negative pregnancy test)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

E

Elizabeth Sachs, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Exercise and Soft Tissue Sarcoma | DecenTrialz